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Completed

NCT Number: NCT06446193

To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD

The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Communication Disorders Mental Disorders Neurodevelopmental Disorders Social Adjustment Social Behavior Social Communication Disorder Social Skills

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, South Korea

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About this study

This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.

The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents between the ages of 10 and 18
  • Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria
  • Participants who are able to install 'NDTx-01' on an Android smartphone and use it alone or with the help of their guardian
  • Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
  • Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
  • Participants who agree that there should be no change in the use of drugs which can significantly affect one's sociality during the clinical trial (If there is a drug being taken during screening, it can be taken continuously, but the total daily dose, ingredients, etc., should remain unchanged until the end of the study visit.)
  • Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/rehabilitation/education, social treatment/rehabilitation/education program (If there is treatment/rehabilitation/education being received during screening, it can be received continuously, but the number of applications and treatment methods should remain unchanged until the end of the study visit.)
  • Participants who and whose parents (legal guardians) have volunteered to participate in this clinical trial and have given written consent to the subject description and consent form
  • Participants willing to comply with the clinical trial procedures

Exclusion criteria

  • A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
  • Severe acute/chronic medical or mental illness
  • Serious trauma or surgery performed within 4 weeks before the screening date
  • Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
  • Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
  • Participants with a previous history of using NDTx-01, the investigational device
  • Participants who have a change in the usage or dosage of drugs which can significantly affect one's sociality, or a change in participation in treatment/rehabilitation/education programs that can significantly affect one's sociality within 8 weeks before the baseline date of the clinical trial
  • In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial

Treatment and study plan

NDTx-01

Device

NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total.

TAU

Behavioral

TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education

Primary outcomes

  1. Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42

    Time frame: Baseline, Day 42

    The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.

Secondary outcomes

  1. Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28

    Time frame: Baseline, Day 28

    The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.

  2. Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42

    Time frame: Baseline, Day 28, Day 42

    The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.

  3. Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42

    Time frame: Baseline, Day 28, Day 42

    The SRS-2 consists of a series of questions answered by parents or caregivers who observe the individual's behavior. It is a tool used to assess social skills, social cognition, and behaviors associated with autism spectrum disorders (ASD) in children and adolescents. It's designed to help clinicians, educators, and researchers identify and understand social impairments commonly seen in individuals with ASD or other developmental disorders. The T scores range from 34 to 128, with higher scores indicating worse outcomes.

  4. Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42

    Time frame: Baseline, Day 28, Day 42

    The K-PRQ-CA is a tool designed to assess the quality of the relationship between parents and their children or adolescents. It's used to evaluate various aspects of the parent-child relationship, including communication, support, discipline, and overall satisfaction. The T scores of K-PRQ-CA are estimated to be 20 to 80 (T score mean 50, standard deviation 10), with higher scores indicating better outcomes.

  5. Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42

    Time frame: Baseline, Day 28, Day 42

    The KIPR is a tool used to assess peer relationships among Korean children and adolescents. It's designed to measure various aspects of peer interactions, including social skills, peer acceptance, peer rejection, and the quality of friendships. The T scores of KIPR are estimated to be 20 to 80 (T score mean 50, standard deviation 10), with higher scores indicating worse outcomes.

  6. Change from Baseline in EQ-5D-5L (EuroQol Five Dimension Five Level Scale) at Day 42

    Time frame: Baseline, Day 42

    The EQ-5D-5L is a standardized measure of health-related quality of life developed by the EuroQol Group. It's used to assess a person's health status and well-being across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The "5L" in EQ-5D-5L stands for "five levels," indicating that each dimension has five response levels ranging from no problems to extreme problems. The score for each dimension is from 1 to 5, with higher scores indicating worse outcomes. And the score ranging from 0 to 100 means that the higher the score, the better the outcome.

  7. Change from Baseline in CGI-S (Clinical Global Impression-Severity) at Day 28 and Day 42

    Time frame: Baseline, Day 28, Day 42

    The CGI-S is a widely used clinician-rated scale designed to assess the overall severity of a patient's condition in clinical trials. Clinicians typically rate the CGI-S on a seven-point scale, where each point represents a different level of severity. The score ranges from 1 to 7, with higher scores indicating worse outcomes.

  8. CGI-I (Clinical Global Impression-Improvement) at Day 28 and Day 42

    Time frame: Day 28, Day 42

    The CGI-I is a clinician-rated scale used to assess changes in a patient's overall clinical condition or improvement over time, particularly in clinical trials. Clinicians typically rate the CGI-I on a seven-point scale, where each point represents a different level of improvement compared to baseline. The score ranges from 1 to 7, with higher scores indicating worse outcomes.

  9. NDTx-01 Satisfaction Questionnaire at Day 42

    Time frame: Day 42

    The 'NDTx-01 Satisfaction Questionnaire' includes 4 questions related to satisfaction with the experience of using the investigational device. The score for each question is from 0 to 10, with higher scores indicating better outcomes.

Sponsors and collaborators

Lead sponsor

Neudive Inc.

Industry

Registry information

Official study title

A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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